A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II, Efficacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Eosinophilic Asthma

This study will assess the efficacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: 610 100mg; Drug: 610 300mg; Drug: placebo

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 610 in adults with severe eosinophilic asthma. Plan to recruit 120 subjects, and the subjects divided into 3 groups: 610 100mg group, 610 300mg group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks and follow-up period of 8 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qinghong Zhou, MD; Phone Number: 18911301578; Email: zhouqinghong@3sbio.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
      • Contact: Min Zhang, Doctor; Phone Number: 13482345145; Email: 13482345145@163.com
      • Contact: Xin Zhou, Bachelor; Phone Number: 13701756821; Email: xzhou53@163.com
      • Principal Investigator: Xin zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study
• Female and male aged 18 to 75 years
• Diagnosed with asthma for ≥12 months that meet GINA
• Within 6 months before screening, treatment with medium to high dose inhaled corticosteroid（ICS，inhaled fluticasone at a dosage of at least 500 μg, or equivalent, daily. ICS can be included in In the ICS/LABA combination preparation）and at least one other additional controller medication, such as long-acting β₂ receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, long-acting Anticholinergic drugs (LAMA), etc. Those medicine must be stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
• Current treatment with maintenance oral corticosteroids (OCS), prednisone dosage must be ≤10 mg, or equivalent, daily, and stable for ≥ 28 days prior to screening and baseline and must continue without dosage changes throughout the study
• In the past 12 months prior to screening， two or more asthma exacerbations history, or at least one time emergency department (ED) visits and/or ICU and/or hospitalization
• Pre-bronchodilator FEV1 <80% predicted value
• Positive of bronchodilator test or positive of bronchial provocation test
• Asthma Control Questionnaire score ≥1.5
• Asthma-related blood eosinophils ≥ 300 cells/μL within 6 months before screening, or asthma-related blood eosinophils ≥ 150 cells/μL at screening
• Male and their partners or female must commit to correct use of one or more effective contraceptive measures of the duration of the trial and for 6 months after the last study drug administration. No fertility, sperm donation, or egg donation plans for at least 6 months after the last study drug administration

Exclusion Criteria:

• With clinically important lung diseases other than asthma that may affect safety or efficacy and evaluated by investigator. This includes lung infection, chronic obstructive pulmonary disease, bronchiectasis, hypersensitivity pneumonitis, pulmonary fibrosis, Allergic bronchopulmonary aspergillosis, etc.
• With other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), or eosinophilic esophagitis
• In past 12 months prior to screening，patients has done bronchial thermoplasty or radiotherapy or plan to do it during of the trial
• with severe cardiac disease or uncontrolled or severe cardiac arrhythmia
• poorly controlled systemic disease
• Active infection that requiring systemic treatment at screening
• Parasitic infection without adequate treatment within 6 months before screening
• Lymphoproliferative disease or any malignancy history within past 5 years prior to screening (Except for received treatment and no recurrence in the past 3 months include basal cell carcinoma, actinic keratosis, carcinoma in situ of cervix, or resected non-invasive malignant colonic polyps.)
• Liver function meets one of the following criteria at screening or before randomization: a) Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) ≥ 2.0×ULN (upper limit of normal); b) Total bilirubin≥1.5×ULN
• At screening, HBsAg or HCV Ab or HIV Ab or TP Ab positive; HBsAg or HCV Ab positive need to be further tested of HBV DNA titer detection or HCV RNA detection (More than normal value range needs to be excluded)
• Subjects who have received any monoclonal antibody treatment within 3 months or 5 half-lives (whichever is longer) before screening, or with poor treatment effect of anti-IL-5/5R
• Vaccination history with live vaccines (including live attenuated vaccines) within 4 weeks before screening, or plan to receive during of the trial
• Participated in any interventional clinical trial and received intervention within 3 months before screening
• Allergy/intolerance to investigational medicinal product.
• Current smokers with average monthly smoking of ≥10 cigarettes within 6 months before screening, or former smokers with a smoking history of ≥10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked)
• Plan to pregnant during of the trial or pregnant or breastfeeding
• Any other things that are not suitable for participating in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; 610 100 mg administered subcutaneously every 4 weeks	Drug: 610 100mg; 100mg administered subcutaneously Q4W
Experimental: Treatment group B; 610 300 mg administered subcutaneously every 4 weeks	Drug: 610 300mg; 300mg administered subcutaneously Q4W
Placebo Comparator: placebo Arm Type：no inter; placebo administered subcutaneously every 4 weeks	Drug: placebo; administered subcutaneously Q4W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at week 16	FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.	Baseline (Day 1) and at week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, and 12	FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry.	Baseline (Day 1) and at week 4,8,12
Percentage change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at weeks 4, 8, 12, 16	Percentage of FEV1 will be measured using spirometry.	Baseline (Day 1) and at week 4,8,12
Number of asthma exacerbation through study week 16	Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.	From baseline (Day 1) to week 16
Time to first asthma exacerbation event	Asthma exacerbation are defined as worsening of asthma which required use of systemic corticosteroids (≥3 days. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits.	From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission) or emergency room visits (not conversion to hospitalization)	Asthma exacerbations that are associated with a hospitalization or an emergency room visit.	From baseline (Day 1) to week 16
Number of asthma exacerbations requiring hospitalization (including intubation and ICU admission)	Asthma exacerbations that are associated with a hospitalization.	From baseline (Day 1) to week 16
Puffs of rescue medication for asthma exacerbations	Albuterol or levalbuterol for an asthma exacerbation is considered rescue medication.	From baseline (Day 1) to week 16
Change from baseline in Asthma Control Questionnaire score at week 4,8,12,16	The ACQ has 7 questions- the first 5 items assess the most common asthma symptoms plus 6. short-acting bronchodilator use and 7. FEV1 (pre-bronchodilator use, % and % predicted use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6= maximum impairment).	Baseline (Day 1) and at week 4,8,12,16
Change From Baseline in the St. George's Respiratory Questionnaire Total Score at week 16	The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health.	Baseline (Day 1) and at week 16

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Investigators: Study Director: Qinghong Zhou, MD, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.; Principal Investigator: Min Zhang, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Xin Zhou, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Asthma; Exacerbations; Placebo; Eosinophilic asthma; 610
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: SSGJ-610-BA-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No